Methotrexate Tablets

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders
  • Leukemias, lymphomas, and other hematologic cancers
  • Psoriasis

Methotrexate Tablets Generic Name & Formulations

General Description

Methotrexate sodium 2.5mg; scored tabs.

Pharmacological Class

DMARD (folic acid antagonist).

How Supplied

Contact supplier

Methotrexate Tablets Indications

Indications

Treatment of adults with rheumatoid arthritis (RA) or children with polyarticular juvenile idiopathic arthritis (pJIA).

Methotrexate Tablets Dosage and Administration

Adult

Initially 7.5mg as a single dose once weekly, or a course of three 2.5mg doses at 12-hr intervals once weekly; max 20mg/week. Give with folic or folinic acid to reduce adverse reactions.

Children

<2yrs: not established. ≥2yrs: initially 10mg/m2 once weekly; adjust dose gradually to achieve optimal response; max 20mg/m2 per week. Give with folic or folinic acid to reduce adverse reactions.

Methotrexate Tablets Contraindications

Contraindications

Pregnancy in patients with non-neoplastic diseases.

Methotrexate Tablets Boxed Warnings

Boxed Warning

Embryo-fetal toxicity. Hypersensitivity reactions. Severe adverse reactions.

Methotrexate Tablets Warnings/Precautions

Warnings/Precautions

Be fully familiar with this drug's toxicity before use. Obtain baseline and monitor CBCs for myelosuppression, and hepatic, renal and pulmonary function; reduce dose, interrupt, or discontinue if needed. Monitor for neurotoxicity, dermatologic toxicity. Avoid excessive sun exposure. Increased risk of serious infections (eg, bacterial, fungal, viral) including opportunistic infections; monitor and treat promptly. Peptic ulcer disease. Ulcerative colitis. Increased risk of hepatotoxicity with alcoholism or receiving total cumulative dose (≥1.5g). Update immunizations according to current guidelines prior to initiation. Permanently discontinue if anaphylaxis, other serious hypersensitivity or severe dermatologic reactions occur. Evacuate significant third-space accumulations prior to administration. Renal or hepatic impairment. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

Methotrexate Tablets Pharmacokinetics

See Literature

Methotrexate Tablets Interactions

Interactions

Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, phenytoin, sulfonylureas, sulfonamides, probenecid, proton pump inhibitors, folic acid antagonists. May be potentiated by penicillins (monitor), tetracyclines, neomycin. May be antagonized by folic acid. Increased risk of leukoencephalopathy with prior cranial radiotherapy. Caution with other hepatotoxic drugs (eg, azathioprine, retinoids, sulfasalazine) and nephrotoxic agents (eg, cisplatin).

Methotrexate Tablets Adverse Reactions

Adverse Reactions

Ulcerative stomatitis, leukopenia, nausea, abdominal distress, elevated liver function tests, malaise, fatigue, chills, fever, dizziness; myelosuppression, infections, renal toxicity, GI toxicity, hepatotoxicity, pulmonary toxicity, dermatologic reactions, secondary malignancies, tumor lysis syndrome, infertility.

Methotrexate Tablets Clinical Trials

See Literature

Methotrexate Tablets Note

Notes

Formerly known under the brand name Rheumatrex.

Methotrexate Tablets Patient Counseling

See Literature

Methotrexate Tablets Generic Name & Formulations

General Description

Methotrexate sodium 2.5mg; scored tabs.

Pharmacological Class

DMARD (folic acid antagonist).

How Supplied

Contact supplier

Methotrexate Tablets Indications

Indications

Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. Treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen. Treatment of adults with relapsed or refractory non-Hodgkin lymphomas (NHL) as part of a metronomic combination chemotherapy regimen.

Methotrexate Tablets Dosage and Administration

Adult

ALL: initially 20mg/m2 once weekly; adjust subsequent dosing based on ANC and platelet count. Mycosis fungoides (as single agent): 25–75mg once weekly; (as part of combination regimen): 10mg/m2 twice weekly. Relapsed/refractory NHL: 2.5mg 2–4 times weekly; max 10mg/week.

Children

ALL: initially 20mg/m2 once weekly; adjust subsequent dosing based on ANC and platelet count.

Methotrexate Tablets Contraindications

Contraindications

Pregnancy in patients with non-neoplastic diseases.

Methotrexate Tablets Boxed Warnings

Boxed Warning

Embryo-fetal toxicity. Hypersensitivity reactions. Severe adverse reactions.

Methotrexate Tablets Warnings/Precautions

Warnings/Precautions

Be fully familiar with this drug's toxicity before use. Obtain baseline and monitor CBCs for myelosuppression, and hepatic, renal and pulmonary function; reduce dose, interrupt, or discontinue if needed. Monitor for neurotoxicity, dermatologic toxicity. Avoid excessive sun exposure. Increased risk of serious infections (eg, bacterial, fungal, viral) including opportunistic infections; monitor and treat promptly. Peptic ulcer disease. Ulcerative colitis. Increased risk of hepatotoxicity with alcoholism or receiving total cumulative dose (≥1.5g). Update immunizations according to current guidelines prior to initiation. Permanently discontinue if anaphylaxis, other serious hypersensitivity or severe dermatologic reactions occur. Evacuate significant third-space accumulations prior to administration. Renal or hepatic impairment. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

Methotrexate Tablets Pharmacokinetics

See Literature

Methotrexate Tablets Interactions

Interactions

Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, phenytoin, sulfonylureas, sulfonamides, probenecid, proton pump inhibitors, folic acid antagonists. May be potentiated by penicillins (monitor), tetracyclines, neomycin. May be antagonized by folic acid. Increased risk of leukoencephalopathy with prior cranial radiotherapy. Caution with other hepatotoxic drugs (eg, azathioprine, retinoids, sulfasalazine) and nephrotoxic agents (eg, cisplatin).

Methotrexate Tablets Adverse Reactions

Adverse Reactions

Ulcerative stomatitis, leukopenia, nausea, abdominal distress, elevated liver function tests, malaise, fatigue, chills, fever, dizziness; myelosuppression, infections, renal toxicity, GI toxicity, hepatotoxicity, pulmonary toxicity, dermatologic reactions, secondary malignancies, tumor lysis syndrome, infertility.

Methotrexate Tablets Clinical Trials

See Literature

Methotrexate Tablets Note

Notes

Formerly known under the brand name Rheumatrex.

Methotrexate Tablets Patient Counseling

See Literature

Methotrexate Tablets Generic Name & Formulations

General Description

Methotrexate sodium 2.5mg; scored tabs.

Pharmacological Class

DMARD (folic acid antagonist).

How Supplied

Contact supplier

Methotrexate Tablets Indications

Indications

Treatment of adults with severe psoriasis.

Methotrexate Tablets Dosage and Administration

Adult

Initially 10–25mg once weekly until adequate response; adjust gradually to achieve optimal response; max 30mg/week. Give with folic or folinic acid to reduce adverse reactions.

Children

Not established.

Methotrexate Tablets Contraindications

Contraindications

Pregnancy in patients with non-neoplastic diseases.

Methotrexate Tablets Boxed Warnings

Boxed Warning

Embryo-fetal toxicity. Hypersensitivity reactions. Severe adverse reactions.

Methotrexate Tablets Warnings/Precautions

Warnings/Precautions

Be fully familiar with this drug's toxicity before use. Obtain baseline and monitor CBCs for myelosuppression, and hepatic, renal and pulmonary function; reduce dose, interrupt, or discontinue if needed. Monitor for neurotoxicity, dermatologic toxicity. Avoid excessive sun exposure. Increased risk of serious infections (eg, bacterial, fungal, viral) including opportunistic infections; monitor and treat promptly. Peptic ulcer disease. Ulcerative colitis. Increased risk of hepatotoxicity with alcoholism or receiving total cumulative dose (≥1.5g). Update immunizations according to current guidelines prior to initiation. Permanently discontinue if anaphylaxis, other serious hypersensitivity or severe dermatologic reactions occur. Evacuate significant third-space accumulations prior to administration. Renal or hepatic impairment. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

Methotrexate Tablets Pharmacokinetics

See Literature

Methotrexate Tablets Interactions

Interactions

Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, phenytoin, sulfonylureas, sulfonamides, probenecid, proton pump inhibitors, folic acid antagonists. May be potentiated by penicillins (monitor), tetracyclines, neomycin. May be antagonized by folic acid. Increased risk of leukoencephalopathy with prior cranial radiotherapy. Caution with other hepatotoxic drugs (eg, azathioprine, retinoids, sulfasalazine) and nephrotoxic agents (eg, cisplatin).

Methotrexate Tablets Adverse Reactions

Adverse Reactions

Ulcerative stomatitis, leukopenia, nausea, abdominal distress, elevated liver function tests, malaise, fatigue, chills, fever, dizziness; myelosuppression, infections, renal toxicity, GI toxicity, hepatotoxicity, pulmonary toxicity, dermatologic reactions, secondary malignancies, tumor lysis syndrome, infertility.

Methotrexate Tablets Clinical Trials

See Literature

Methotrexate Tablets Note

Notes

Formerly known under the brand name Rheumatrex.

Methotrexate Tablets Patient Counseling

See Literature